Exploring gut immunity's role in neurologic diseases
Intestinal Immunity in Neurologic Disease
This study is trying to see how immune cells in the gut might affect diseases like Multiple Sclerosis and Parkinson's by looking at tissue samples from people having a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (North Haven, Connecticut) |
| Trial ID | NCT06329453 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the functional profiles of immune cells in the gastrointestinal tract and their contribution to autoimmune and neurologic diseases such as Multiple Sclerosis and Parkinson's Disease. Participants undergoing colonoscopy will provide tissue biopsies from the gastrointestinal mucosa, allowing researchers to analyze immune cell interactions in detail using modern single-cell technologies. The study seeks to uncover the relationship between gut immunity and neurologic disease pathogenesis, potentially shifting current paradigms in understanding these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who are undergoing a colonoscopy as part of standard care or are willing to participate in a research colonoscopy.
Not a fit: Patients with chronic inflammatory gastrointestinal diseases or those currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the role of gut immunity in neurologic diseases, potentially informing future therapeutic strategies.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated the importance of gut microbiome and immunity in neurologic diseases, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and up ONE of the following: * Recommended to under a screening colonoscopy (+/- upper endoscopy) as part of standard of care. This includes healthy individuals as well as those with neurologic and/or autoimmune diseases. OR * Willing to undergo research colonoscopy (+/- upper endoscopy) for research Exclusion Criteria: * Currently pregnant. Women of childbearing potential would perform a point of care urine pregnancy test prior to colonoscopy/endoscopy. * Known or suspected, chronic inflammatory gastrointestinal disease (e.g. inflammatory bowel disease) * Known, acute or chronic infections * Systemic antibiotic (PO or IV) use within 3 months of colonoscopy * Systemic corticosteroid use (equivalent of prednisone 10 mg per day or higher for \>5 days) within 2 weeks of colonoscopy * Malignancy, diagnosed or treated within the last 5 years * Probiotic use within 2 weeks of procedure * History of major GI surgery (e.g. colon resection, gastric bypass) * Bleeding disorder, or on anticoagulant medication * Other medical condition that, in the judgement of the investigator, would lead to higher-than-expected risks of biopsy * Allergy to MAC anesthesia or other drugs used pursuant to standard of care for biospecimen collection
Where this trial is running
North Haven, Connecticut
- Yale MS Clinic — North Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Erin Longbrake — Yale University
- Study coordinator: Cynthia Marques
- Email: cynthia.marques@yale.edu
- Phone: 2032876100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.